Prospective Study Registry of Peripheral Neuroblastic Tumours Presenting With Spinal Canal Involvement (SCI) (NB-SCI)
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|ClinicalTrials.gov Identifier: NCT02559804|
Recruitment Status : Unknown
Verified July 2016 by Associazione Italiana Ematologia Oncologia Pediatrica.
Recruitment status was: Recruiting
First Posted : September 24, 2015
Last Update Posted : January 26, 2017
|Condition or disease||Intervention/treatment|
|Neuroblastic Tumors||Other: survival and late effects|
Multi-centre, observational, prospective study registry. About 15% of patients with peripheral neuroblastic tumour present with extradural SCI, of whom approximately 60% are symptomatic. Since SCI may progress to irreversible paraplegia, early diagnosis and prompt treatment is of critical importance.1-3 The treatment options include chemotherapy, neurosurgical decompression and radiation therapy. All may relieve epidural compression, but there is no consensus on which to use first in the individual patient. However, the choice of the treatment could be relevant in the perspective of reducing to the minimum the risk of long-term sequelae.4 Guidelines for the diagnostic work-up and treatment of SCI for International Society of Paediatric Oncology European Neuroblastoma (SIOPEN) neuroblastoma patients were already available in the "guidelines for the treatment of patients with localized resectable neuroblastoma and analysis of prognostic factors" (LNESG1 Protocol), back in 1994,5 although it is unknown how they were applied in the SIOPEN Centres. These guidelines have been reformulated in occasion of the recently activated "European Low and Intermediate risk Neuroblastoma" (LINES Protocol).
There are few publications addressing the diagnosis and treatment of SCI; most are retrospective studies, case reports, or reviews that may be affected by reporting bias.1-9 Therefore new guidelines could be designed based on the information derived from a prospective data collection of newly diagnosed patients.
For this study Spinal Canal Involvement (SCI) is defined when, referring to an axial plane of the spinal cord MRI scan (Figure 1), the tumour extends into the vertebral canal and goes beyond a mentally drown ellipsoid (red circle) passing through the cortical bone of both anterior and posterior arches of the vertebra. This involvement is called "intraspinal" or, better, "intracanal".
Patient data to be collected and included in the corresponding Forms
- work-up at diagnosis, including radiology report (Computed Tomography or Magnetic Resonance Imaging)
- treatment administered
- response to treatment, including radiology report
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||150 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Prospective Study Registry of Peripheral Neuroblastic Tumours Presenting With Spinal Canal Involvement (SCI)|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||April 2018|
patients NB with SCI
Survival and late effects. Diagnosis of peripheral neuroblastic tumour - peripheral neuroblastic tumour (neuroblastoma, ganglioneuroblastoma, ganglioneuroma) presenting with SCI, symptomatic or asymptomatic, independent of disease extension (stage), and clinical course (first diagnosis or relapse/progression).
Other: survival and late effects
survival and late effects
- prevalence of neurologic consequences [ Time Frame: for 5 years ]American Spinal Injury Association ASIA impairment scale
- prevalence of orthopedic consequences [ Time Frame: for 5 years ]using Common Terminology Criteria for Adverse Events v. 4.0
- prevalence of pain [ Time Frame: for 5 years ]using Face, Legs, Activity, Cry, Consolability scale (FLACC scale)
- relapse or second tumour [ Time Frame: 5 years ]event free survival
- survival [ Time Frame: 5 years ]overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02559804
|Contact: Riccardo Haupt, MD||01056363462 ext +firstname.lastname@example.org|
|Contact: tiziana landi||051/2144667 ext +email@example.com|
|Principal Investigator:||Riccardo Haupt, MD||Istituto Giannina Gaslini Genova|